A senior FDA official moved on Monday to take over the agency's vaccine office.

Dr Peter Marks, one of the Food and Drug Administration’s most senior regulators, took over the agency’s vaccine office on Monday, whose...


Dr Peter Marks, one of the Food and Drug Administration’s most senior regulators, took over the agency’s vaccine office on Monday, whose two executives had publicly asked whether the general population needed booster vaccines. against coronaviruses.

Dr Marks said in an email to staff that the move, which makes him the acting director of the office, would allow the two – Marion Gruber, the director of the vaccine bureau, and Dr Philip Krause, his deputy – to “take care of the pre-departure closing activities and help ensure a smooth transition.”

Dr Gruber recently announced his intention to retire at the end of October, and Dr Krause in November.

The two have evaluated vaccines for decades at the agency’s Office of Vaccine Research and Review, and would have been upset when the Biden administration announced last month that booster injections would be available to most adults by the week of September 20, subject to FDA clearance.

The two regulators wrote in The Lancet earlier this month that there was not yet credible evidence to support booster injections for the general population, and that more data and public discussion was needed. Their position was shared by many independent scientists, who said coronavirus vaccines continue to be powerfully protective against serious illness and hospitalization.

After a tension Meet of the FDA’s Vaccine Advisory Board, Dr. Gruber last week sign the agency’s decision note behind its authorization of Pfizer-BioNTech booster injections for people 65 years of age and over, people at high risk of severe Covid-19 and others at risk of serious complications from Covid-19 whose jobs frequently expose them to the virus.

The CDC Advisory Committee on Vaccines cast a similar vote, but did not approve the offer of boosters based on his work. Dr Rochelle P. Walensky, director of the agency, canceled advisers and recommended plans for people based on “professional or institutional environment”.

President Biden said last week that 60 million people would be eligible for a Pfizer-BioNTech recall over the next few months.

The FDA’s office of vaccines has more important decisions to make, including whether or not to approve the Pfizer-BioNTech vaccine for children aged 5 to 11 and recalls for Moderna and Johnson & Johnson vaccine recipients.

As director of the FDA’s Biologics Assessment and Research Center, Dr. Marks, hematologist and oncologist, oversaw the vaccine bureau’s reviews for the entire pandemic. He is credited as the architect of the Trump administration’s vaccination program, Operation Warp Speed, which developed and funded coronavirus vaccines.

But Jesse Goodman, the agency’s former chief scientist, said Dr Marks’ decision to take over the office was “extremely unusual and concerning.” He said the FDA had to offer a clear explanation otherwise it could “erode trust” in the agency. “It just doesn’t make sense to me,” he said.

“These are the two people who know the most about vaccines at the FDA, and they should do everything possible to keep them involved in all critical activities,” he said, referring to Dr Gruber and the Dr Krause.

Some administration officials said Dr Marks’ action made sense as the upcoming departures of Dr Gruber and Dr Krause could delay critical vaccine decisions if no one else was in charge. Dr Eric Topol, professor of molecular medicine at Scripps Research in La Jolla, Calif., Praised Dr Marks’ experience and said “new leadership was vital” after Dr Gruber and the Dr. Krause had expressed it so strongly that the booster shots were not warranted for everyone.

But Dr Luciana Borio, the former acting chief scientist of the FDA under President Barack Obama, said Dr Marks could have brought in someone else. “There are several well qualified people in the office,” she said, “and I was surprised that one of them was not promoted to acting director.”

An FDA spokeswoman said in a statement Monday that “a smooth transition is especially important given the critical regulatory submissions that the Office of Vaccines Research and Review will need to work on as a team over the next few months, which will affect the health of almost all Americans. “

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Newsrust - US Top News: A senior FDA official moved on Monday to take over the agency's vaccine office.
A senior FDA official moved on Monday to take over the agency's vaccine office.
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